RESUMEN
BACKGROUND: Multiple sclerosis is a chronic, autoimmune, degenerative disease. Therapies targeting B-cells have been shown to be effective in its treatment; however, there are few studies evaluating their efficacy in the Mexican population. OBJECTIVE: To evaluate the clinical impact of rituximab in patients with newly-diagnosed relapsing-remitting multiple sclerosis (RRMS). MATERIAL AND METHODS: Real life, descriptive study, in which rituximab was evaluated as treatment for RRMS over a 24-month period. Pre- and post-treatment clinical variables were analyzed; a comparison was made between treatment-naïve and non-treatment-naïve patients. RESULTS: Twenty-eight patients with RRMS were included. Mean age at diagnosis was 30.7 years, and 22 patients were treatment-naïve (78.5 %). After 24 months, there was a mean reduction of 1.8 points in the EDSS scale and a decrease in the number of active lesions on magnetic resonance imaging; a significant difference in both variables could be established (p < 0.05). However, the logistic regression model did not show a relationship between the variables for achieving NEDA-3 criteria. No serious adverse events were observed. CONCLUSIONS: Treatment with rituximab resulted in significant clinical and radiological improvement in treatment-naïve and non-treatment-naïve Mexican patients with RRMS.
ANTECEDENTES: La esclerosis múltiple es una enfermedad crónica, autoinmune y degenerativa. Las terapias blanco contra los linfocitos B han probado ser efectivas en su tratamiento; sin embargo, existen pocos estudios que evalúen su eficacia en población mexicana. OBJETIVO: Evaluar el impacto clínico del rituximab en pacientes con esclerosis múltiple remitente recurrente (EMRR) de reciente diagnóstico. MATERIAL Y MÉTODOS: Estudio de vida real, descriptivo, en el que se evalúa rituximab como tratamiento de EMRR durante un periodo de 24 meses. Se analizaron variables clínicas pre y postratamiento; se realizó la comparación entre pacientes naïve y no naïve. RESULTADOS: Se incluyeron 28 pacientes con EMRR. La edad media al diagnóstico fue de 30.7 años y 22 pacientes fueron naïve (78.5 %). Después de 24 meses, se observó una reducción media de 1.8 puntos en EDSS y en el número de lesiones activas por resonancia magnética. Aunque se logró establecer una diferencia significativa en ambas variables con p < 0.05, el modelo de regresión logística no mostró una relación entre las variables para alcanzar un NEDA-3. No se observaron eventos adversos graves. CONCLUSIONES: El tratamiento con rituximab resultó en mejoría significativa clínica y radiológica en pacientes mexicanos con EMRR naïve y no-naïve.
Asunto(s)
Esclerosis Múltiple Recurrente-Remitente , Esclerosis Múltiple , Humanos , Rituximab/uso terapéutico , Esclerosis Múltiple/tratamiento farmacológico , Factores Inmunológicos/uso terapéutico , México , Centros de Atención Terciaria , Esclerosis Múltiple Recurrente-Remitente/tratamiento farmacológico , Esclerosis Múltiple Recurrente-Remitente/inducido químicamenteRESUMEN
BACKGROUND: Early initiation with high efficacy therapies seems to be better than an escalation approach in terms of disability prevention in patients with relapsing-remitting MS (RRMS). Although efficacy and safety of cladribine tablets have been shown in clinical trials, real-world evidence (RWE) studies from Latin America are scarce. OBJECTIVE: To describe the baseline characteristics of patients enrolled in the Argentina Patient Support Program (PSP) for cladribine tablets (Adveva®), with at least 1 treatment course, evaluate treatment persistence, adverse event reports from PSP patients and reported relapses characterization. METHODS: Anonymized data routinely collected by Adveva® team of patients that received the first dose of cladribine from April 16th 2018 to March 31st 2021 were analyzed. Treatment persistence was defined as the percentage of patients that initiated year 2 (Y2) from the population of patients with elapsed time since year 1 (Y1) cladribine tablet initiation of at least 18 months. In addition, using the pharmacovigilance data, reported adverse events and the time elapsed from treatment initiation to relapse were analyzed. RESULTS: The present analysis included 269 patients (mean age: 41.7 ± 16 years) that had initiated Y1 of cladribine tablets treatment between April 16th 2018 and March 31st 2021. Although only 29.4% (79/269) of our population was treatment naïve, the ratio of naïve/switch patients that initiated cladribine tablets increased from April 2018-March 2019 to April 2020-March 2021. From the 110 patients with elapsed time since treatment initiation ≥18 months, 101 patients initiated Y2 indicating a persistence level of 91.8%. During follow-up, 425 adverse events were reported, mainly MS relapse (8.9%, 38/425), fatigue (3.8%, 16/425) and headache (3.5%, 15/425). Lymphopenia and infections were rarely reported by RRMS patients treated with cladribine tablets. MS relapse was more frequently reported in patients switching from a previous treatment (87.5%, 27/32) than in the naïve cohort (12.5%, 5/32). CONCLUSIONS: The first real life experience in RRMS patients from Latin America demonstrated that the Adveva® enrolled support program patients have a high persistence level to oral treatment with cladribine tablets. Our results also confirmed the known safety profile of cladribine tablets, with a low incidence of lymphopenia and infections.
Asunto(s)
Linfopenia , Esclerosis Múltiple Recurrente-Remitente , Esclerosis Múltiple , Humanos , Adulto , Persona de Mediana Edad , Cladribina/uso terapéutico , Inmunosupresores/efectos adversos , Argentina , Esclerosis Múltiple Recurrente-Remitente/tratamiento farmacológico , Esclerosis Múltiple Recurrente-Remitente/inducido químicamente , Linfopenia/inducido químicamente , Comprimidos , Esclerosis Múltiple/tratamiento farmacológicoRESUMEN
BACKGROUND: Physical disability, cognitive impairment, depression, and fatigue are poorly understood in Latin American patients with multiple sclerosis following alemtuzumab infusion. OBJECTIVES: To describe Sustained changes in physical disability in an average 22-month follow-up period after alemtuzumab infusion, and which demographical or clinical variables modulate change in EDSS, and adverse events, changes in cognition, fatigue, and depressive symptoms after an average 15-month follow-up period. METHOD: Retrospective cohort observational study. Following the review of medical records, 23 patients with Relapsing Remitting Multiple Sclerosis treated with alemtuzumab were identified; of these, 17 had a baseline neuropsychological assessment and 12 had at least one follow-up neuropsychological assessment. RESULTS: Most of the patients presented a low level of physical disability, depression, fatigue, and cognitive impairment, which was more pronounced in the processing speed and visuospatial memory at baseline. Fifteen of 23 (65.2%) of patients showed disability improvement, 7 (30.1%) patients remained stable, and 1 (4.3%) patient worsened, and change was not influenced by age or baseline disability score. Twenty (87%) patients remained free of clinical relapses. Performance improved on the BVMT-R visual memory test, 9 (75%) remained stable or improved on the BICAMS, and 66.6% perceived decreased fatigue on the d-FIS. Adverse events occurred in 7 (30.1%) of patients, the most common were opportunistic infections in 2 (8.6%) patients, and one 29-year-old patient presented papillary thyroid carcinoma after infusion of the second course of alemtuzumab. CONCLUSIONS: Results suggest that treatment with alemtuzumab has a beneficial impact on disability, cognitive impairment, and perception of fatigue. The percentage and type of adverse events observed in the cohort are similar to those reported for other real-life studies.